BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM QUATTRO CATHETER

    MDR report key: 11963175 · Received June 8, 2021

    Report

    Report Number
    3010617000-2021-00543
    Event Type
    Malfunction
    Date Received
    June 8, 2021
    Date of Event
    May 10, 2021
    Report Date
    June 8, 2021
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075282
    PMA / PMN Number
    K101987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED COMPLAINT OF A LEAKING QUATTRO CATHETER (LOT #153696) WAS CONFIRMED DURING FUNCTIONAL TESTING. A PINHOLE LEAK WAS OBSERVED AT PROXIMAL END OF MEDIAL 1 BALLOON. THE INVESTIGATION FINDINGS REVEALED THAT THE PROBABLE CAUSE OF THE REPORTED COMPLAINT WAS DUE TO A LATENT MATERIAL DEFECT. VISUAL INSPECTION OF THE RETURNED QUATTRO CATHETER WAS PERFORMED. THE BALLOONS WERE EXAMINED AND THERE WERE NO TEARS, BALLOON BOND DETACHMENT OR RUPTURE NOTED. DRIED BLOOD WAS OBSERVED ON THE BALLOONS AND LUERS TUBINGS. DURING FUNCTIONAL TESTING, ALL LUMENS WERE FLUSHED WITHOUT RESISTANCE, EXCEPT FOR THE IN/OUT LUERS DUE TO CLOGGED WITH BLOOD. THE CATHETER WAS CONNECTED TO A PRESSURIZED INFLATION DEVICE AND A PINHOLE LEAK ON PROXIMAL END OF THE MEDIAL 1 BALLOON WAS OBSERVED. THUS, CONFIRMING THE REPORTED COMPLAINT. DURING MANUFACTURING ALL QUATTRO CATHETERS ARE 100% INSPECTED FOR LEAKS BY SUBJECTING THEM TO PRESSURE TESTING. ONLY UNITS THAT PASSED ARE MOVED TO THE NEXT PROCESS. THEREFORE, IT IS UNLIKELY THAT THE CATHETER WAS DEFECTIVE WHEN SHIPPED. HISTORICAL COMPLAINTS WERE REVIEWED FOR SERVICE INFORMATION RELATED TO THE REPORTED COMPLAINT AND THERE WAS NO SIMILAR COMPLAINT REPORTED FOR QUATTRO CATHETER WITH LOT NUMBER 153696.

    Description of Event or Problem · 1

    DURING COOLING PHASE OF IVTM THERAPY, THE USER OBSERVED BLOOD IN THE START-UP KIT TUBING, SUSPECTING A LEAK ON THE QUATTRO CATHETER (LOT# 153696). AFTER REMOVING THE CATHETER, THE USER TRIED TO REWIRE ANOTHER QUATTRO CATHETER (SN UNKNOWN), HOWEVER,WAS UNABLE TO PERFORM CATHETERIZATION. FOLLOWING THIS, IVTM THERAPY WAS DISCONTINUED AND ADJUNCT THERAPY WAS PERFORMED. NO CONSEQUENCES OR IMPACT TO PATIENT. PLEASE SEE THE FOLLOWING RELATED MFR REPORT: MFR # 3010617000-2021-00561 FOR QUATTRO CATHETER LOT# UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850444 ZOLL IVTM QUATTRO CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION IC-4593 153696 00849111075282

    Patients

    Seq Age Sex Outcome Treatment
    1